MAUDE Adverse Event Report: SMITH & NEPHEW, INC. IMAGE MANAGEMENT SYSTEM 660HD-E; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL

Catalog Number	72204668
Medical Device Problem Codes	No Display/Image (1183); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 660hd-e image management system had found unsatisfactory as the unit had an ¿intermittent auto shutting down during surgery".30 minutes delay and a back up was available to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of shutting down by itself could not be reproduced.Unit passed functional testing during 6 hour burn-in including capture and print function.Unit did not shut down during burn-in.All video inputs/outputs normal and unit's display performed as expected.Both analog and digital video outputs were tested during burn-in.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: IMAGE MANAGEMENT SYSTEM 660HD-E
• Common Device Name: DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8927890
• Report Number: 1643264-2019-00563
• Device Sequence Number: 290839
• Product Code: LMB
• UDI-Device Identifier: 00885556623695
• UDI-Public: 00885556623695
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72204668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 07/27/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1